title: Noninferiority of a task-shifting HIV care and treatment model using peer counselors and nurses among Ugandan women initiated on ART: evidence from a randomized trial.
abstract: OBJECTIVE
  To assess the noninferiority of a task-shifting HIV treatment model relying on peer counselors and nurses compared with a physician-centered model among HIV-1-positive women initiated on antiretroviral therapy (ART) at a prevention of mother-to-child transmission clinic in Mulago Hospital, Uganda.
  
  
  METHODS
  HIV-1-infected ART eligible naive women were randomized to either nurse-peer (intervention) or doctor-counselor (standard model) arm. The primary endpoint was virologic success defined attaining a viral load < 400 RNA copies per milliliter 6-12 months after ART initiation. Noninferiority was defined as the lower 95% confidence limit for the difference in proportions with virologic success being less than 10%. Secondary outcomes included immunologic success (mean CD4 count increase from baseline) and pill count.
  
  
  RESULTS
  Data on 85 participants were analyzed (n = 45 in the intervention and n = 40 in the standard model). The proportion of participants with virologic success was similar in the standard and intervention models [91% versus 88% respectively; difference, 3%; 95% confidence interval (CI): -11% to 12%]. Probability of viral detection at 6-12 months' time point was similar in the 2 models (log-rank test P = 0.73). Immunologic and pill count indicators were also similar in the intervention and standard models, with mean CD4 increase of 217 versus 206 cells per microliter (difference, 11; 95% CI: -60 to 82 cells/μL) and pill counts of 99.8% versus 99.7% (difference, 0.0; 95% CI: -5% to 5%) respectively.
  
  
  CONCLUSIONS
  Nurses and peer counselors were not inferior in providing ART follow-up care to postpartum women, an approach that may help deliver treatment to many more HIV-infected people.
authors.affiliation: Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda. fmatovu@mujhu.org
authors.forename: Flavia M
authors.initials: FM
authors.lastname: Kiweewa
authors.forename: Deo
authors.initials: D
authors.lastname: Wabwire
authors.forename: Jessica
authors.initials: J
authors.lastname: Nakibuuka
authors.forename: Mike
authors.initials: M
authors.lastname: Mubiru
authors.forename: Danstan
authors.initials: D
authors.lastname: Bagenda
authors.forename: Phillippa
authors.initials: P
authors.lastname: Musoke
authors.forename: Mary G
authors.initials: MG
authors.lastname: Fowler
authors.forename: Gretchen
authors.initials: G
authors.lastname: Antelman
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D003376:Counseling; D005260:Female; D006679:HIV Seropositivity / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1; D006801:Humans; D055118:Medication Adherence; D017146:Models, Organizational; D024802:Nurse's Role; D010379:Peer Group; D010819:Physician's Role; D049590:Postpartum Period; D057184:Practice Patterns, Nurses'; D014454:Uganda; D019562:Viral Load; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents